Signal detection support
Article 23
The Agency shall support the monitoring of the Eudravigilance database by providing national competent authorities with access to the following information: (a) data outputs and statistical reports allowing a review of all adverse reactions reported to the Eudravigilance database in relation to an active substance or a medicinal product; (b) customised queries supporting the evaluation of individual case safety reports and case series; (c) customised grouping and stratification of data enabling the identification of patient groups with a higher risk of occurrence of adverse reactions or with a risk of a more severe adverse reaction; (d) statistical signal detection methods. The Agency shall also ensure appropriate support for the monitoring of the Eudravigilance database by marketing authorisation holders.